UCB (EBR:UCB) UCB Media Room: UCB acquires Engage Therapeutics

Transparency directive : regulatory news

05/06/2020 07:00

https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6elthyCx8hVpJYOyOR-2F7537EF7814R9sC-2BJPmzuiiNlaH-2BWzGa= h7fe6v-2BJ-2B6dSeSZyd9-2FvketmCqwrL6kgaUsfiQwCGe_xDPID0vOuylFAU8fv4e60wei4J= xqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj= -2F2X9c9g1wasiCtbTEDUqagHT2IfNV-2FKF-2B-2FHv9lseWF8lRDsxxh4wC-2F-2BumIrF9yk= u7c8ujhjEL6Ul7BXVBGABYx4cU-2BjIeT-2BK1pNUQnh-2FwpgmQrwlIyVvHWO155Vh7nU4kZUG= IOOtabPd2g-2BrcstXK4gWqrBILVMNzYjbGhD9QAFYx248NXC-2B5Stk-2BiGk9xrusAvMf0NRu= iL7qQmEBplY4KcfaD8mFvGaHbgN9tGE285uTOphzgH9-2BLa8vX0-2Fm2a-2BOTzh9beqp8-3D ** UCB acquires Engage Therapeutics: Staccato^=C2=AE Alprazolam - A potenti= al solution for acute on-demand seizure management for people living with e= pilepsy ------------------------------------------------------------ =C2=B7 Underlines UCB=E2=80=99s leadership in epilepsy by adding Staccato^= =C2=AE Alprazolam, a drug-device-combination with the potential to be the f= irst on-demand, single-use treatment to rapidly terminate an active epilept= ic seizure =C2=B7 Staccato^=C2=AE Alprazolam could be a potential solution for 20-30% = of epilepsy patients=C2=A0 =C2=B7 UCB to have world-wide rights to Staccato^=C2=AE Alprazolam and woul= d perform further clinical development, submission, launch and commercializ= ation of Staccato^=C2=AE Alprazolam =C2=B7 Initial upfront payment of US$ 125 million and further potential mil= estone payments of up to US$ 145 million, total potential consideration of = up to US$ 270 million. =C2=B7 License and supply agreements in place with Alexza Pharmaceuticals, = Inc., the inventor, licensor and manufacturer of Staccato^=C2=AE Alprazolam= .=C2=A0 Brussels (Belgium) 05 June 2020 =E2=80=93 7:00 (CEST) - regulated informati= on =E2=80=93 inside information =E2=80=93 UCB announced today the acquisiti= on of Engage Therapeutics, Inc. (Summit, N.J. (U.S.)), a clinical-stage pha= rmaceutical company developing Staccato^=C2=AE Alprazolam for the rapid ter= mination of an active epileptic seizure, for US$ 125 million in cash (subje= ct to certain adjustments) and up to US$ 145 million in further potential m= ilestone payments related to clinical development, submission and launch of= Staccato^=C2=AE Alprazolam.=C2=A0 Charl van Zyl, Executive Vice President UCB and Head of Neurology said: =E2= =80=9CLike UCB, Engage is a company with a deep-seated passion in epilepsy.= Several of Engage=E2=80=99s founders and leaders have personal connections= to epilepsy and have been active in the epilepsy community for quite some = time. Staccato^=C2=AE Alprazolam is an excellent strategic fit with our pat= ient value growth strategy in epilepsy. It offers a potential solution for = acute, on-demand treatment of a seizure, an unmet need for up to 30% of all= epileptic patients, and strengthens our current epilepsy portfolio by addi= ng this late-stage asset.=E2=80=9D Staccato^=C2=AE Alprazolam is an investigational drug (Phase 2) designed to= be used as a single-use epileptic seizure rescue therapy that combines the= Staccato^=C2=AE delivery technology with alprazolam, a benzodiazepine. It = is a small, hand-held inhaler device designed for easy delivery of alprazol= am with a single normal breath potentially providing a way for people with = epilepsy and their caregivers to stop an active seizure. The Staccato^=C2= =AE system rapidly vaporizes alprazolam to form an aerosol, with particle s= ize designed for deep lung delivery to produce a rapid, systemic effect.=C2= =A0 Engage acquired worldwide rights to Staccato^=C2=AE Alprazolam in 2017 unde= r a license agreement with Alexza Pharmaceuticals Inc., Mountain View, CA, = U.S. In connection with the acquisition, UCB has also entered into an updat= ed license and related commercial supply agreement with Alexza, under which= the parties will continue to collaborate in the development and commercial= ization of Staccato^=C2=AE Alprazolam. This acquisition does not impact UCB=E2=80=99s 2020 financial outlook. Advisors Lazard is acting as financial advisor to UCB in relation to the transaction= . Covington & Burling LLP is acting as legal advisor to UCB on the transact= ion. KPMG is acting as accounting advisor.=C2=A0 BMO Capital Markets Corp. is acting as financial advisor to Engage Therapeu= tics. Morgan, Lewis & Bockius LLP is acting as legal advisor to Engage Ther= apeutics.=C2=A0 About Engage Therapeutics Engage Therapeutics, Summit, N.J., now a wholly-owned subsidiary of UCB, is= a clinical stage pharmaceutical company with a deep-seated passion in epil= epsy. Engage is developing Staccato^=C2=AE Alprazolam for the rapid termina= tion of an active epileptic seizure. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With more than 7 500 people in= approximately 40 countries, UCB generated revenue of =E2=82=AC 4.9 billion= in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Tw= itter: @UCB_news For further information, UCB: Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 Jim Baxter,=C2=A0 Neurology Communications, UCB T+32.2.473.78.85.01 jim.baxter@ucb.com=C2=A0 Forward looking statements UCB=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e actual results, financial condition, performance or achievements of UCB, = or industry results, to differ materially from those that may be expressed = or implied by such forward-looking statements contained in this press relea= se. Important factors that could result in such differences include: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t liability claims, challenges to patent protection for products or product= candidates, competition from other products including biosimilars, changes= in laws or regulations, exchange rate fluctuations, changes or uncertainti= es in tax laws or the administration of such laws, and hiring and retention= of its employees. There is no guarantee that new product candidates will b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products which are the subject of partnersh= ips, joint ventures or licensing collaborations may be subject to differenc= es disputes between the partners or may prove to be not as safe, effective = or commercially successful as UCB may have believed at the start of such pa= rtnership. UCB=E2=80=99 efforts to acquire other products or companies and = to integrate the operations of such acquired companies may not be as succes= sful as UCB may have believed at the moment of acquisition. Also, UCB or ot= hers could discover safety, side effects or manufacturing problems with its= products and/or devices after they are marketed. The discovery of signific= ant problems with a product similar to one of UCB=E2=80=99s products that i= mplicate an entire class of products may have a material adverse effect on = sales of the entire class of affected products. Moreover, sales may be impa= cted by international and domestic trends toward managed care and health ca= re cost containment, including pricing pressure, political and public scrut= iny, customer and prescriber patterns or practices, and the reimbursement p= olicies imposed by third-party payers as well as legislation affecting biop= harmaceutical pricing and reimbursement activities and outcomes. Finally, a= breakdown, cyberattack or information security breach could compromise the= confidentiality, integrity and availability of UCB=E2=80=99s data and syst= ems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. GenericFile UCB Engage press release June 05 2020 (https://u7061146.ct.sendgrid.net/ls/= click?upn=3D4tNED-2FM8iDZJQyQ53jATUb5139PTmAm2ORJ-2Fb7C-2B6elthyCx8hVpJYOyO= R-2F7537EK42dAZ7aw-2FbIMTNuIgSjKeGEtkAOEjzaENaFiJVbcHY-3DKV2u_xDPID0vOuylFA= U8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2F= OeoCOG9ekocVj-2F2X9c9g1wasiCtbTEDUqagHT2IfNV-2FKF-2B-2FHv9lseWF8lRDsxxh4wC-= 2F-2BumIrF9yku7c8ujhjEL6Ul7BXVBGABYx4cU-2BjIeT-2BK1pNUQnh-2FwpgmQrwlIyVvBTF= YyzypYdhYVIO4URbZJBHtIB5FGxGTWKn4TmvjExAJPujfD-2FfnF-2FCPXh-2FXeWoVnVw0JE-2= BVQBGH-2B7fe0wNAkmsjsOBL-2B15Bn-2F2vZ-2BBFTVMj-2Fcsy5rp1H0L-2B1Y6r54-2Fy-2B= 1QDuuXSwarqszFfWqGPUw-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jAT= UeYfdhr1xEBQnaPhR2RKx1tfe2VKDZTewv5u80JomRcXP56QiPWlxCYoY-2BF6nKKdK8r86IV9k= ZlEBquSqRL3VueablE2DgF9Pp-2BDRXQsa6Xy5dWBISmDWFT-2BdqZiHAg3pWq3it7ijsGbk4KX= KRARRI0-3Dq9yD_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0Kx= vPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wasiCtbTEDUqagHT2IfNV-2F= KF-2B-2FHv9lseWF8lRDsxxh4wC-2F-2BumIrF9yku7c8ujhjEL6Ul7BXVBGABYx4cU-2BjIeT-= 2BK1pNUQnh-2FwpgmQrwlIyVvCUVfwyFNxEshSLaBcVBUx-2FYSH3O3QHnGfzwMllKS64R-2BzH= U2w5AF-2FFe9m11kH8O4YMNSV-2Fv7bsw3JaNi19sMZ7KpU9BdtLdFNTpOtdVuzA6czdRSMYUlN= Xq2l1Oga50tlCeFIImaEyRqHAu7E14ijw-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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UCB (EBR:UCB) UCB Media Room: UCB acquires Engage Therapeutics

Transparency directive : regulatory news

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